FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel i
FDA device recall Z-1843-2014 · posted 2014-06-20 · Terminated
Recall details
- Recalling firm
- BioFire Diagnostics, Inc.
- Reason for recall
- BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioMrieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.
- Action taken
- BioFire Diagnostics sent an Urgent Recall/Correction letter on May 28, 2014. Customers were instructed If the BCID Panel is used to test BacT/ALERT SN bottles, positive results for Pseudomonas aeruginosa and Enterococcus should be confirmed by another method prior to reporting the test results. Customer with questions were instructed contact customer support at Support@biofiredx.com or via telephone by dialing 1-800-735-6544 and selecting option 5 for customer support and then option 1 for FilmArray. For questions regarding this recall call 801-736-6354, ext 360.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- PAM
- Quantity affected
- 1084
- Distribution
- Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA.
- Date initiated
- 2014-05-27
- Date posted
- 2014-06-20
- Date terminated
- 2014-11-07
- Location
- Salt Lake City, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (K130914) | Biofire Diagnostics, Inc. | 2013-06-21 |